Pliant Therapeutics, Inc. (NASDAQ: PLRX) has announced an accelerated development plan for its lead product candidate, bexotegrast, in the treatment of idiopathic pulmonary fibrosis (IPF). The company's pivotal, adaptive phase 2b/3 trial, named beacon-ipf, has been accepted by the European Union and other global health authorities, which will significantly reduce the time to phase 3 data compared to a traditional phase 3 trial.
Following the acceptance of the trial design, Pliant Therapeutics will be implementing beacon-ipf as a phase 2b/3 operationally seamless, adaptive design, enabling patients to enroll in the phase 3 component immediately after the completion of the phase 2b component. The company will augment the sample size by 90 patients, allowing both components to potentially support registration with minimal impact on timelines.
In terms of financials, Pliant Therapeutics has amended its $100 million loan facility with Oxford Finance LLC, upsizing it to a total size of $150 million of available non-dilutive capital. This, combined with the company's cash and cash equivalents of $495.7 million as of December 31, 2023, is expected to fund Pliant through 2026.
Bexotegrast, an oral, small molecule, dual-selective inhibitor of αvß6 and αvß1 integrins, has received fast track and orphan drug designations from the U.S. Food and Drug Administration (FDA) in IPF and primary sclerosing cholangitis (PSC), as well as orphan drug designation from the European Medicines Agency in IPF and PSC.
Pliant Therapeutics is also developing other product candidates, including pln-1474 for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis, and pln-101095 for the treatment of solid tumors.
As a result of these announcements, the company's shares have moved 6.4% on the market, and are now trading at a price of $15.46. For the full picture, make sure to review Pliant Therapeutics's 8-K report.
